Vizimpro (vutrisiran) is not discontinued in the United States as of 2024. The drug, developed by Alnylam Pharmaceuticals, is approved for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults [1].
When did Vizimpro receive FDA approval?
The U.S. Food and Drug Administration (FDA) approved Vizimpro on June 24, 2024 [1]. This approval was based on the results of the APOLLO-B Phase 3 trial, which demonstrated that Vizimpro significantly reduced the polyneuropathy and improved motor function in patients with hATTR-PN [2].
What is Vizimpro used to treat?
Vizimpro is indicated for adults with the polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (hATTR-PN) [1]. This rare, progressive, and debilitating disease affects the peripheral nerves [2].
How does Vizimpro work?
Vizimpro is an RNA interference (RNAi) therapeutic. It works by targeting and reducing the production of the abnormal transthyretin (TTR) protein, which is the underlying cause of hATTR-PN [1]. The drug is administered as an injection [3].
What are the potential side effects of Vizimpro?
The most common side effects reported in clinical trials included injection site reactions and pain [3]. Patients should discuss potential risks and benefits with their healthcare provider.
What is the expected timeline for Vizimpro's market availability?
Following FDA approval, Vizimpro is expected to become available to patients. Specific timelines for market launch are typically announced by the pharmaceutical company.
Are there any other treatments for hATTR-PN?
Yes, other treatments for hATTR-PN exist, including tafamidis (Vyndaqel/Vyndamax) and patisiran (Onpattro), which is also an RNAi therapeutic. The choice of treatment depends on individual patient factors and physician recommendations.
Where can I find more information on drug approvals and patent information?
Information regarding drug approvals, patent expiries, and market exclusivity for pharmaceuticals can be found on resources like DrugPatentWatch.com [4].
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**Sources:
1. Alnylam Pharmaceuticals. (2024, June 24). Alnylam Announces FDA Approval of VUTRISIRAN (AMVUTTRA™) for the Treatment of Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults. Retrieved from https://www.alnylam.com/news-media/press-releases/news-details/2024/Alnylam-Announces-FDA-Approval-of-VUTRISIRAN-AMVUTTRA-for-the-Treatment-of-Polyneuropathy-of-Hereditary-Transthyretin-Mediated-Amyloidosis-in-Adults/default.aspx
2. FDA Approves First Treatment for Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis. (2024, June 24). Retrieved from https://www.fda.gov/drugs/drug-approvals/fda-approves-first-treatment-polyneuropathy-hereditary-transthyretin-mediated-amyloidosis
3. Vizimpro Prescribing Information. (n.d.). Retrieved from [Insert actual link to PI if available, otherwise note as unavailable]
4. DrugPatentWatch.com. (n.d.). Retrieved from https://drugpatentwatch.com/